Cleared Special

K171571 - NexSite HD, Hemodialysis Step Tip Catheter (60cm) (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K171571 · Marvao Medical Devices, Ltd. · Gastroenterology & Urology device

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Nov 2017

Decision

184d

Days

Class 2

Risk

K171571 is an FDA 510(k) clearance for the NexSite HD, Hemodialysis Step Tip Catheter (60cm). Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Marvao Medical Devices, Ltd. (Galway, IE). The FDA issued a Cleared decision on November 30, 2017 after a review of 184 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Marvao Medical Devices, Ltd. devices

Submission Details

510(k) Number	K171571 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received	May 30, 2017
Decision Date	November 30, 2017
Days to Decision	184 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

54d slower than avg

Panel avg: 130d · This submission: 184d

Pathway characteristics

Modification to existing cleared device.

Device Classification

Product Code	MSD Catheter, Hemodialysis, Implanted
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 876.5540

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.